Pharmacokinetics, Safety & Tolerability of Treprostinil Inhalation Powder

Status Completed

Clinical Trial Summary

A Dose-Rising Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers

Clinical Trial Description

Up to 48 subjects will be enrolled in 8 cohorts of 6 subjects each. The treatments are intended to establish the maximum tolerated dose in healthy normal volunteers, starting at 30 mcg. Each subject will receive one dose of Treprostinil Inhalation Powder by oral inhalation during the treatment period.

A total of 12 pharmacokinetic blood samples will be collected from each subject. Plasma pharmacokinetic samples will be analyzed for treprostinil. ;

Study Design

Related Conditions & MeSH terms

Familial Primary Pulmonary Hypertension
Hypertension
Pulmonary Arterial Hypertension

Clinical Trial Details

NCT number	NCT03464864
Study type	Interventional
Source	Mannkind Corporation
Contact
Status	Completed
Phase	Phase 1
Start date	March 9, 2018
Completion date	June 5, 2018

View Details

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